Generic Name and Formulations:
Amlodipine (as besylate), benazepril (as HCl); 2.5mg/10mg, 5mg/10mg, 5mg/20mg, 5mg/40mg, 10mg/20mg, 10mg/40mg; caps.

Company:
Novartis Pharmaceuticals Corp
Indications for LOTREL:
Hypertension (not for initial therapy).

Adult:
For patients not adequately controlled with either a dihydropyridine calcium channel blocker or an ACE inhibitor or in those who show inability to achieve BP control with amlodipine without developing edema: Initially 2.5mg/10mg once daily; may titrate up to 10mg/40mg once daily if BP remains uncontrolled. Replacement therapy: may be substituted for titrated components. CrCl ≤30mL/min: not recommended. Hepatic impairment, elderly: consider lower doses.

Children:
Not recommended.

Contraindications:
History of ACEI-associated or other angioedema. Concomitant aliskiren in patients with diabetes.

Warnings/Precautions:
Fetal toxicity may develop; discontinue if pregnancy is detected. Salt/volume depletion. Renal or hepatic impairment. Dialysis (esp. high-flux membrane). Renal artery stenosis. CHF. Severe obstructive coronary artery disease. Severe aortic stenosis. Obstructive hypertrophic cardiomyopathy. Diabetes. Surgery. Discontinue if angioedema, laryngeal edema, jaundice or marked elevation in liver enzymes occurs. Monitor BP, electrolytes and renal function. Black patients may have higher risk of angioedema than non-black patients. Neonates. Elderly. Neonates. Pregnancy (Cat.D); monitor. Nursing mothers: not recommended.

Interactions:
See Contraindications. Dual inhibition of the renin-angiotensin system with ARBs, ACEIs, or aliskiren may increase risk of hypotension, hyperkalemia, renal function changes; monitor closely, in general, avoid combined use of RAS inhibitors. Avoid aliskiren in renal impairment (CrCl <60mL/min). Hyperkalemia with K+supplements, K+ -sparing diuretics, or salt substitutes. May increase lithium levels. Potentiates simvastatin (max 20mg daily). Potentiated by diuretics, CYP3A4 inhibitors. Nitritoid reactions with concomitant injectable gold (sodium aurothiomalate); rare. May be antagonized by, and renal toxicity potentiated by, NSAIDs, including selective COX-2 inhibitors (monitor renal function periodically in elderly and/or volume depleted). Hypoglycemia with insulin and oral antidiabetics; rare. Increased risk of angioedema with concomitant mTOR inhibitor (eg, temsirolimus, sirolimus, everolimus).

Pharmacological Class:
Calcium channel blocker (dihydropyridine) + ACE inhibitor.

Adverse Reactions:
Cough, edema, fatigue, dizziness, GI upset, angioedema, hypotension, hyperkalemia, palpitations, flushing, anaphylactoid reactions; rare: hepatic failure.

How Supplied:
Caps—100